Valves enabling a liquid to be directed in a diagnostic chart diagnostic charts and diagnostic device comprising several charts

ABSTRACT

A valve ( 2 ), crossed by at least one channel ( 3 ), allowing to direct at least one fluid (F 5 ) displaced by a transfer device within a test sample card ( 1 ), the card ( 1 ) featuring two faces ( 4  and  5 ) connected to one another ( 4 ) ( 5 ) by an edge ( 6 ). A card equipped with a device allowing several cards equipped with such valves to be implemented is made up of a flexible film ( 7 ), and/or which can be distorted, part of which is fixed to at least one of the faces ( 4  and/or  5 ) of said card ( 1 ) on the one hand, and a film compression device ( 7 ), which can be deactivated on the other hand. In addition, securing is carried out on at least one of the plane faces ( 4  and/or  5 ), for example, by a securing device located at the level of a recession ( 9 ) peripheral to the valve ( 2 ), such as a groove ( 9 ). The valve is particularly applicable in the field of diagnosis.

This application is a U.S. National Stage of International applicationPCT/FR00/01719, filed Jun. 21, 2000 and published on Dec. 28, 2000 inthe French Language, and which claims priority of French PatentApplication 99/08116, filed Jun. 22, 1999.

DESCRIPTION

This invention concerns the field of valves used to direct at least onefluid displaced by transfer systems within a test sample card. It alsoconcerns a card equipped with a device allowing several cards equippedwith such valves to be implemented.

Up until now, most test sample cards have recesses on both of theirplane and parallel faces as well as crosswise recesses, all of therecesses forming a channel network in which one or more fluids aredisplaced. On the face of the cards, said recesses are marked out byadhesive films. Fluid displacement is controlled by valves.

This type of structure is not reusable, as a valve can only be usedefficiently once. Thus, when the valve is tipped into closed position,the adhesive surface of the film also comes into contact with the restof the card, and the valve can therefore no longer be used. The valveremains in closed position.

The only solution thus remaining is the deposit on an inert, that isnon-adhesive film, of an adhesive layer having cut-outs which have beenpreviously removed by a punch.

Technically speaking, this is not easy to achieve. Also, the cost ofmanufacturing such film in addition to the difficulties encountered inpositioning the film on the test sample card would be incompatible withmass production in large quantities.

The applicant filed a patent application on Sep. 8, 1998, underapplication number FR98/11383. This invention concerns a device or testsample card enabling a reaction or at least two reactions to beconducted therein in parallel or in series. The device consists of anetwork of channels wherein the transfer of at least one sample to betreated and/or analyzed is possible, on the one hand, and at least onevalve built into the device, on the other hand, enabling the orientationof each sample transferred at the network level and thus the control oftransfers, reactions and analyses in said device. In the embodimentshown in FIGS. 1 through 3, it can be seen that an elastomer disk isinserted between the adhesive film ard the body of the card, whichallows the valve to be reused.

This structure thus provides a solution, although it increases thenumber of elements and the manufacturing cost of a functional testsample card.

Document WO-A-97/27324 attempts to provide a solution to this problem.Thus, it concerns a cassette to conduct reactions in parallel whichfeatures an entry and exit orifice to transfer the sample(s) to beintroduced into the cassette. Valves are present at cassette level,which have a particular construction (Bursapak chamber, piston valve,bead valve). Under a continuous outside force, these valves allow achannel to be held closed. In this embodiment, the film is heat-sealedto the cassette.

However, this construction has a major disadvantage. The disadvantageresides in the deformation of the face of the cassette onto which thefilm is heat-sealed. While this face is originally plane, theheat-sealing weld causes distortion which is detrimental to subsequentproper use of the cassette. This could range from an error inmanipulation and/or analysis to rendering the valves inoperable. Theworst problems may be encountered when this type of cassette is used byan automated controller, which is generally the case. In thisconfiguration, the card, which is warped by the heat-seal, may block oreven damage the automated controller assembly.

Another disadvantage of this innovation is that it is absolutelynecessary that the film is precisely heat-sealed onto the card. Even atiny error may lead to channel blockage and/or valve leakage.

This invention provides a concrete response to all of the disadvantagesof prior art. Thus, the film is heat-sealed onto the body of the testsample card without damaging the surface where the heat-seal is made.Furthermore, the tolerance for the heat-sealing position is greater, asit only outlines the area that makes up the valve and does not follow itclosely.

To this effect, this invention concerns a valve, with at least onechannel running through it, allowing at least one fluid displaced bytransfer means within the test sample card to be directed, the cardfeaturing two faces connected one another by an edge, characterized inthat it consists of a film, which is flexible and/or which can bedeformed, secured partly on at least one of the faces of said card, andby a film compression means, which can be activated or deactivated, andin that their securing is made at least on one of the faces, for examplea plane one, by a securing means located at the level of a recessionsurrounding the valve, such as a groove.

According to an alternative embodiment, the securing of the film on thecard is peripheral to the set of channels concerned by the valve (i.e.at least one fluid entry channel and at least one fluid exit channel),both fluids may be identical or different.

According to another alternative embodiment, the securing is carried outby a heat seal peripheral to the valve.

According to still another alternative embodiment, the compression meansacts on the film at the intersection between at least one of the valvechannels and the face of the card in question.

According to yet another alternative embodiment, the compression meansconsists of a flexible tab.

According to yet another alternative embodiment, the compression meansfeatures a closure mechanism, such as an elastomer pin, and an openingor closing mechanism, such as a wedge, which synergizes with actuationmechanisms.

According to a preferred embodiment, at least two valves are positionedside by side, and the means assigned to compressing the valves, thelatter being positioned side by side, are connected together to form astrip assembly.

Preferably, two adjacent valves positioned side by side are separated byspacing of between 1 and 5 mm, and preferably with spacing having valuesused in the field of electronics, such as 3.96 mm, 2.54 mm or 1.28 mm.

According to another preferential embodiment, the film near the valve isin contact with the plane face of the card when said valve is in closedposition, and is elevated in relation to said plane face when the valveis in open position.

The invention also concerns a test sample card made up of a multiplicityof valves described above which are, fully or partly, distributed alongat least one edge of said card.

When the card is in more or less parallelepiped arrangement, theedge(s), where the valves are located, is (are) rectilinear, and thedistance separating said edge is constant, in relation to the locationof each valve.

The invention concerns a device enabling the implementation of severalcards, described above. This device consists of the following:

-   -   a storage area for the cards which are placed parallel to one        another,    -   a valve opening and closing inspection area associated with        manual or automatic control, and    -   an intermediate area used as an interface between the storage        and inspection areas.

According to a preferential embodiment, the cards are arranged in thestorage area with all valves on the same edge located within the sameplane facing the intermediate area; the inspection area consists ofactuators, such as electromagnets, whose longitudinal movements are madein the direction of said intermediate area, and this intermediate areaconsists of maneuvering pins having at least two positions, one positionwhich allows valve opening and the other allowing valve closure.

According to another embodiment, the device features one actuator percard and one maneuvering pin per valve.

According to yet another embodiment, the actuator's movement is coaxialto the longitudinal axis of the maneuvering pin and valve, which isactivated and deactivated.

According to yet another embodiment, all of the actuators are installedin the same plane and are mobile along an axis parallel to the planeformed by all of the edges of the cards having valves which could beactuated by these actuators.

According to another embodiment, the maneuvering pins have two possiblepositions, one allowing the valves to be opened and the other allowingthe valves to be closed, each position being on each side of a confiningelement.

Preferably, the confining element is mobile between two extremepositions, one where it prevents any pin movement and the other wherethe movement of said pins is possible.

The accompanying drawings are given by way of example and are not to betaken as in any way limiting. They are intended to make the inventioneasier to understand.

FIG. 1 represents a perspective view of a test sample card according toa preferred embodiment of this invention.

FIG. 2 represents a perspective view of the bottom of one of theflexible strip assemblies shown in FIG. 1.

FIG. 3 shows a cross-sectional view through A—A in FIG. 1.

FIG. 4 represents a view of the top of the test sample card, with thetabs removed.

FIG. 5 represents a cross-sectional view along B—B of FIG. 4, when thevalve is in closed position.

FIG. 6 represents a cross-sectional view identical to FIG. 5, when thevalve is in open position.

FIG. 7 represents a cross-sectional view identical to FIG. 3, althoughthe tab has a different structure and operates in a manner opposite thatof the previous figures.

FIG. 8 represents a cross-sectional view, prior to assembly byheat-sealing, of a test sample card body and a flexible film accordingto background art.

FIG. 9 represents a cross-sectional view, after assembly byheat-sealing, of a test sample card body and a flexible film accordingto background art.

FIG. 10 represents a cross-sectional view, prior to assembly byheat-sealing, of a test sample card body and a flexible film accordingto this invention.

FIG. 11 represents a cross-sectional view, after assembly byheat-sealing, of a test sample card body and a flexible film accordingto this invention.

FIG. 12 represents a partial cross-sectional view of a device allowingseveral cards equipped with the valves described above to beimplemented.

Finally, FIG. 13 shows a cross-sectional view through C—C in FIG. 12.

This invention concerns the problems of heat-sealing films onto a solidsupport such as the body of the test sample card. The background art iswell represented in FIGS. 8 and 9 where it can be seen that the card 20consists essentially of two opposite faces, parallel to one another andperfectly flat. A film 21 is located in the vicinity of one of thesefaces, as is clearly shown in FIG. 8. After heat-sealing 22 has beenperformed, it can be clearly seen on FIG. 9 that the body 20 isdistorted and also lead the film 21 to be distorted. In this manner,this distortion induces depressions and elevations on the surface of thebody of the card 20 which are detrimental to further use of this card,and which can also cause weakening in certain spots of the film 21. Theassembly may be damaged and possibly prevent the card from being usedfor future analyses.

The purpose of this invention is thus to eliminate the problem ofheat-sealing films onto a support, such as a test sample card which isgenerally made of plastic material.

In FIGS. 10 and 11, it can be seen that the body of said card 1 featuresa groove 9 or recession in a certain location which will receive thereinpart of the flexible film 7, said film 7 and the body of the card 1being held together by a weld 10 located in the bottom of the groove 9.As a result, the heat-seal weld 10 does not distort the upper surface ofthe card 1 and thus presents no subsequent problem in using said card 1and in performing analyses.

FIG. 1 shows a general perspective view of an embodiment according tothe invention. The valves are partially represented as will be discussedbelow. Thus in this figure, the flexible film 7 as well as all of theelements that make up the valve inside the body of the card 1 are notrepresented although they are actually present. Nevertheless, theelements which are represented are important. Firstly, a strip assembly13 can be seen which is made up of several tabs 8 and is fixed on thecard 1 by a securing means 23. These tabs 8 extend onto one fo the sidesof the strip assembly 13 more or less perpendicularly to this stripassembly 13, with all of the tabs 8 being parallel to each other. Inaddition, the distance separating two adjacent tabs 8 is constant, insuch a way that there is a space separating all of the adjacent tabs 8.Preferably, this distance is identical to the spacing used in electronicapplications, in order to reduce the cost of manufacturing stripassemblies 13 or to use actuators which already exist in the backgroundart. Such spacing may be between 1 and 5 mm, and more precisely is equalto 3.96 mm, 2.54 mm or 1.28 mm.

At the level of said blade strip assembly 13, there is direct contactbetween the body of the card 1, and of course between the film 7, notshown in this figure, and this strip assembly 13. Toward the right-handside of the figure, an oblique face can be seen then a face parallel tothe upper surface of the card 1 and finally another oblique face, bothoblique faces forming an angle of more or less 90° between them,although this value is in no way limiting. At the bottom of the secondoblique face, there is another parallel face near the upper surface ofthe card 1. This face enables the channel 3, that is integral with theunderlying valve 2, to be directly opened or closed. On the right-handside of this face there is a last beveled face 12 designed to synergizewith a piston-type actuator 14, located at the far right of this figure.

The head of the piston-type actuator 14 is cone shaped; this shapeallows the head to engage between the beveled edge 12 of the openingmeans of the flexible tab 8 and the beveled surface 19 of the card 1.This beveled surface 19 is present between the first upper face 4 andthe edge 6 of said card 1, with this card 1 also including a secondlower face 5.

The face of the flexible tab 8, which allows closure, is equipped with aclosing means 11 or an elastomer pin 11 whose function will be describedlater. This pin 11 and the opening means or beveled face 12 are clearlyshown in FIG. 2.

In both FIGS. 1 and 3, it can be seen that the whole set of piston-typeactuators 14 is mounted on a support 16, while each piston-type actuator14 is supplied with compressed air in the direction of F1 or F2 by meansof compressed air hoses 15.

In FIG. 3 and in combination with FIG. 1, it is easier to understand howthis device works. When compressed air enters the hose 15, thepiston-type actuator 14 is displaced in the direction of F3 and the tab8 is pushed in the direction of F4. When, conversely, the compressed airleaves the system in the direction of F2, the movements of thepiston-type actuator 14 and the tab 8 are reversed in relation to arrowsF3 and F4 in FIG. 3.

In FIG. 3 it can be seen that valve 2 is closed when the closing meansor elastomer pin 11 compresses the intersection point of a channel 3with the surface of the test sample card 1 where the film 7 is located.

FIG. 4 represents a top view of FIG. 1 in the case where all of theflexible tabs 8 have been removed. In this case, it can be seen thateach valve 2 is made up of a small plane surface on the same level asthe rest of the plane surface of said card 1 (also see FIGS. 5 and 6),this small surface including at least one inlet channel 3 and one outletchannel 3, the intersection point between this surface and the fluidinput and output channels 3 being in contact with the film 7 as can beclearly seen in FIG. 5. In this case, the valve is closed. In FIG. 5, itcan be seen that the elastomer pin 11 is schematically represented inorder to clearly show that it blocks one of the two channels 3. Ofcourse, the pin 11 may block either channel or both channels 3.Furthermore, the valve may have more channels, that is three or more.

It can also be seen that the card features a certain number ofcompartments 17. The compartments 17 are connected to the valves bymeans of channels 3. It is also possible, although not represented inthe figure, that other valves and other compartments are located on therest of the card 1 which allows mixing between two networks of channels3 located in parallel and not in series. This is clearly represented inFIG. 4 where it can be seen that the movement of fluids in the directionof F6 on the card 1 may bring two liquids together for mixing or foranalysis within a compartment 17.

In FIGS. 5 and 6, it can now be seen that, on the upper valve 4 of card1, there is a flexible film 7 which is not adhesive, as explained in thesection dealing with background art. This film 7 is thus heat-sealed inthe peripheral groove 9 around the valve 2. Nevertheless, on the bottomface 5 of said card 1, an adhesive film 21, well know in prior art, canalso be used. Of course, depending on the fact that valves 2 are locatedon one side or on both sides of card 1, it is also possible that asecond flexible film 7 is present on this other side. The upper 4 andlower 5 faces are connected together by an edge 6 which features achamfered surface 19 on at least one of the sides, as is shown in FIGS.1, 3 and 4 through 6.

The fluid or fluids in the test sample card 1 are displaced within thiscard 1 by means of a pressure or vacuum that is created. The movement offluid in the direction of F6 in FIG. 6 is achieved by raising the pin 11in the direction of F4, so that the flexible film can be distorted andthe fluid can move in the direction of F5 as is clearly displayed.

According to a second embodiment of the invention, the role of saidflexible tab 8 can be reversed. Thus, in FIG. 7, it can be seen that theflexible tab according to another embodiment features a closing means orwedge 18 at its free end which is opposite of that shown in other FIGS.1 through 3. It can be noted that the piston-type actuator 14 does notact below the wedge 18 but on top of it, in such a manner that when saidpiston-type actuator 14 is in position, as shown in FIG. 7, the valve isopen. However, as soon as compressed air is injected in the direction ofF1, the actuator moves in the direction of F3 and the tab moves in thedirection of F7, that is downward which closes the underlying valve.

A card 1 according to this invention thus has a more or lessparallelepiped shape, preferably a rectangular parallelepiped. All ofthe edges 6 are thus linear and are thus capable of receiving valves 2according to the invention, such as described above.

Preferably, at least one of the two long edges 6 only feature valves 2.In FIG. 13, only one edge 6 is partially represented as only fouradjacent valves are represented.

FIG. 12 represents the three essential areas which form the device.There are, inserted into the device, the inspection area 32 on the left,and the storage area 31 of the cards 1 on the right, and an intermediatearea 33 which serves as an interface between the storage area 31 and theinspection area 32.

The storage area 31 consists of a storage drawer for example, not shown,featuring grooves designed to position each card 1 with constant spacingbetween the cards 1.

The inspection area 32 consists of a framework featuring two uprights orworm screws 27, which, by turning simultaneously, allow the movement ofa mobile trolley 16 which supports all of the piston-type actuators orelectromagnet-type actuator 14. Each of these electromagnet-typeactuators 14 has a piston which can be moved longitudinally from theleft to the right of FIGS. 12 and 13 or vice versa.

The intermediate area 33 thus forms the link between areas 31 and 32described above. The intermediate area 33 consists of the following:

-   -   a fixed guide plate 25 for the valve 2 maneuvering pins 24, the        valves 2 being supported by the cards 1 located in the storage        area 31, as a result of the application of the        electromagnet-type actuators 14 of the inspection area 32,    -   a programming grid or mobile counter plate 26 which allows the        pins 24 to be held in their given position, and    -   said maneuvering pins 24.

In FIGS. 12 and 13, it can be seen that there are as many pins 24 asthere are valves 2, although there is just one electromagnet-typeactuator 14 for the valves 2 of the same card 1. Of course, this is notlimiting and it is possible to have several electromagnet-type actuators14 for the valves 2 of the same card 1.

Programming of the position of the valves, either open or closed, isthus performed by removing the counter plate 26 in order to disengagethe previous positions of the pins 24, by activating theelectromagnet-type actuators 14 in order to place said pins 24 in eitheran “in” or “out” position in relation to said plate 26, and by replacingthe counter plate 26 so that the position of the pins is in relationwith the open or closed valves that are desired. Tests have shown thatonly 100 milliseconds (ms) are required to program all of the valves 2located in the same plane on the cards 1, by means of all the actuators14. When there are ten (10) valves 2 per card 1 and ten (10) cards 1 areactivated, 2.5 seconds are required to change the configuration of fourhundred seventy (470) valves 1.

Each maneuvering pin 24 consists of an active part 29 and a shoulder 30forming a stop, the assembly having a general “nail” shape. The activepart 29 easily slides in the bore 34 provided in the plate 25, but alsoin the groove of the plate 26 designed to hold the shoulder 30 inposition. However, said shoulder 30 is blocked between plate 25 andplate 26 when the pin 24 opens the valve 2, and is blocked only by plate26 when said pin 24 closes said valve 2.

The plate 25 thus appears as a grid having as many bore holes 34 asthere are pins 24. As for it, the plate 26 looks like a “comb”.

If it is easy to understand the movement of the pins 24 from theretracted position to the extended position, with reference to FIGS. 12and 13, as only the deployment of the electromagnet is all that isneeded, things would be different for the opposite movement. Thus, inorder to shift from the extended position to the retracted position, itis possible to magnetize the free end of the electromagnet which is incontact with said pin 24 or to insert a spring between the pin 24 andthe counter plate 26 or any other means of prior art. It is also worthproviding all means which allows said pins 24 to be held in the bores34.

The presence of O-rings 28 should also be noted between said plates 25at the level of the bores 34, as well as the maneuvering plate 24.

REFERENCES

-   1. Test sample card-   2. Valve-   3. Channel-   4 and 5. Faces of the card 1-   6. Edge of the card 1-   7. Flexible film and/or which can be distorted-   8. Compression means of the film 7 or flexible tab-   9. Recession or groove peripheral to the valve 2-   10. Peripheral weld located in the bottom of the groove 9-   11. Hermetic closure means or elastomer pin-   12. Opening device or wedge-   13. Strip assembly consisting of several tabs 8-   14. Piston or programming electromagnet type actuator-   15. Compressed air hose-   16. Mobile trolley or support-   17. Compartment of the card 1-   18. Bevel or closing means-   19. Beveled surface of the card 1-   20. Body of the card according to prior art-   21. Film according to prior art-   22. Weld between the body of the card 20 and the film 21-   23. Strip assembly 13 securing means-   24. Maneuvering pin-   25. Fixed guide plate for pins 24-   26. Mobile counter plate or programming grid-   27. Worm screw-   28. Ring seal-   29. Active part of each pin 24-   30. Shoulder forming a stop on each pin 24-   31. Storage area-   32. Inspection area-   33. Intermediate area used as an interface between the storage area    31 and inspection area 32-   34. Bore in the plate 25 designed to allow the pins 24 to slide-   35. Grove in the plate 26 designed to hold the shoulder 30 in    position-   F1. Inlet of compressed air for actuating means 12-   F2. Outlet of compressed air for actuating means 12-   F3. Movement of actuating means 12-   F4. Tipping of the tab 8-   F5. Fluid transfer at the valve 2 level-   F6. Fluid movements at the card 1 level-   F7. Tipping of the tab according to the embodiment of FIG. 7

1. A valve, crossed by at least one channel, allowing to direct at leastone fluid displaced by transfer means within a test sample card, thecard featuring two faces connected to one another by an edge, whereinsaid valve comprises a flexible film, and/or which can be distorted,part of which is fixed to at least one of the faces of said card, and afilm compression means, which may be activated or deactivated, andwherein a securing of the film on the card is made on at least one ofthe faces, by means of a securing feature located at the level of arecess provided around the valve.
 2. The valve of claim 1, wherein thesecuring of the film on the card is peripheral to a set of channelsassociated with the valve, comprising at least one fluid entry channeland at least one fluid exit channel, whether the fluids are identical ordifferent.
 3. The valve of claim 1, wherein the securing is ensured by aheat seal peripheral to the valve.
 4. The valve of claim 1, wherein thecompression means acts on the film at the intersection point between atleast one of the channels of the valve and one of the two faces of thecard.
 5. The valve of claim 1, wherein the compression means comprises aflexible tab.
 6. The valve of claim 1, wherein the compression meansfeatures a closing means, and an opening and closing means, whichsynergizes with the actuation mechanisms.
 7. The valve of claim 6,wherein said closing means comprises an elastomer pin.
 8. The valve ofclaim 6, wherein said opening and closing means comprises a wedge. 9.The valve of claim 1, wherein the film on the valve is in contact withthe plane face of the card, when said valve is in closed position, andis lifted in relation to said plane face, when the valve is in openposition.
 10. A test sample card comprising at least two valves of claim1, which are positioned side by side and are fully or partly distributedalong at least one edge of said card, and provided with compressionmeans dedicated to the compression of the valves, positioned side byside.
 11. The card of claim 10, having a substantially parallelepipedarrangement, wherein the edge(s) where the valves are located, is (are)rectilinear, and in that the distance separating said edge in relationto the location of each valve is constant.
 12. The card of claim 10,wherein two adjacent valves positioned side by side are separated by aspace between 1 and 5 mm.
 13. The card of claim 12, wherein said spacehas a value selected from the group consisting of 3.96 mm, 2.54 mm and1.28 mm.
 14. A device for enabling the implementation of several cards,said cards being defined according to claim 10, said device comprising astorage area for the cards which are placed parallel to one another,with all of the valves on the same edge located within the same planefacing an intermediate area, a valve opening and closing inspection areaassociated with a manual or automatic control system, and made up ofactuators, for which longitudinal movements take place in the directionof said intermediate area, and said intermediate area which serves as aninterface between the storage area and the inspection area, thisintermediate area comprising maneuvering pins having at least twopositions, one position which allows opening and the other allowingclosure of valves.
 15. The device of claim 14, wherein the device hasone actuator per card, and wherein there is one maneuvering pin pervalve.
 16. The device of claim 14, wherein the movement of the actuatoris coaxial to the longitudinal axis of the maneuvering pin and thevalve, which is activated or deactivated.
 17. The device of claim 14,wherein the set of actuators are mounted in the same plane and aremobile along an axis parallel to the plane formed by all of the edges ofthe cards having the valves which can be activated by these actuators.18. The device of claim 14, wherein the maneuvering pins have twopossible positions, one allowing the opening and the other allowing theclosure of the valves, each position being on each side of a confiningelement.
 19. The device of claim 18, wherein the confining element ismobile between two extreme positions, one where it prevents the pinsfrom moving, and the other where the movement of said pins is possible.20. The device of claim 14, wherein said actuators compriseselectromagnets.
 21. The card of claim 10, wherein said compression meansare connected together.
 22. The valve of claim 1, wherein at least oneof said faces is a plane face.
 23. The valve of claim 1, wherein saidrecess is a groove.